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The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament. resulting in detachment of the implant segment.

The provided text describes a 510(k) submission for the MicroPlex Coil System (MCS) – HyperSoft® 3D, which is a neurovascular embolization device. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (K131948, K153594). The document focuses on performance data from bench testing and biocompatibility assessments rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested details, such as human reader improvement with AI assist, ground truth establishment for training data, and expert adjudication, are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "All test samples passed testing" for bench tests and specific results for biocompatibility tests (e.g., "Non-toxic", "No sensitizer response").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document states "All test samples passed testing" for bench tests, implying that the samples tested for each specific bench test (visual inspection, dimensional measurement, advancement/retraction force, simulated use, spring constant) constituted the test set for those attributes. However, the exact number of samples for each test is not specified in the provided text. For biocompatibility, the tests are performed on material samples rather than a "set" of clinical cases.
• Data Provenance: The data is generated from bench testing and biocompatibility studies conducted by the manufacturer, MicroVention, Inc., located in Tustin, California, USA. This is an in-vitro and ex-vivo type of data provenance, not human clinical data. The tests are prospective in the sense that they are specifically designed and performed to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study did not involve human interpretation of clinical data where a "ground truth" would be established by experts. The "ground truth" for the performance tests comes from engineering specifications, material science standards, and established biological safety protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). The presented studies are engineering and biological safety tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (embolization coils), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of AI's effect on human readers was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these studies is based on:

• Engineering Specifications: For visual inspection, dimensional measurement, advancement/retraction force, simulated use, and spring constant, the ground truth is adherence to the device's design specifications and functional requirements.
• International Standards (ISO): For biocompatibility tests, the ground truth is defined by the passing criteria outlined in the referenced ISO standards (e.g., ISO 10993-3, -4, -5, -6, -10, -11). These standards represent established scientific consensus on acceptable biological responses.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. No training set was used.

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